BioVie reports Long COVID trial data

• BioVie reported Phase 2 ADDRESS-LC results for bezisterim in patients with Long COVID.
• The overall trial population did not reach statistical significance across its 22 measured endpoints.
• High-symptom subgroups showed statistically significant improvements in fatigue, cognitive measures, and post-exertional malaise.

BioVie (NASDAQ:BIVI) reported topline Phase 2 ADDRESS-LC trial results for bezisterim in Long COVID, showing statistically significant improvements in pre-specified subgroups with higher baseline fatigue, cognitive impairment, and post-exertional malaise.

The randomized, double-blind, placebo-controlled trial included 203 patients and evaluated 22 clinical endpoints without a single primary endpoint, with 21 endpoints numerically favoring bezisterim in the overall intent-to-treat population.

BioVie said the overall population results were affected by many participants having low baseline symptom burden, while high-burden subgroups showed larger treatment effects and statistically significant results across fatigue, post-exertional malaise, and objective cognitive measures.

BioVie said the subgroup findings are exploratory and require confirmation in a prospective Phase 3 trial, while bezisterim showed safety and tolerability results similar to placebo.

BioVie develops therapies targeting neurological, inflammatory, and aging-related conditions, including investigational treatments for diseases with limited treatment options.

The ADDRESS-LC study was fully funded through a $13.13 million U.S. Department of War award supporting Long COVID research.